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Some sponsors may be seeking to supply disinfectants for the first time during the COVID-19 pandemic.
This page provides guidance for new sponsors in relation to the supply, import, and export of disinfectant products.
A disinfectant is a substance intended by the manufacturer to be applied to an inanimate object to kill microorganisms. Examples of inanimate objects include curtains, floors, bench tops, lounge furniture and carpets.
Disinfectants are typically supplied in the form of liquids, sprays, wipes, sponges and aerosols.
The following are not disinfectants:
For full definitions of disinfectants, refer to Part 1, Section 2 of the Therapeutic Goods Regulations 1990.
In Australia, disinfectants are regulated under the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019 as either an exempt disinfectant or listed disinfectant depending on the claims made by the product on its labels, packaging and product information leaflets.
Listed disinfectants must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia.
Disinfectants that make non-specific claims are regulated as exempt disinfectants and are not required to be listed in the ARTG prior to their supply.
Examples of non-specific claims include but are not limited to:
Refer to the Disinfectant Claim Guide for further details.
While exempt disinfectants are not required to be included in the ARTG before they are supplied, they must still meet all relevant regulatory requirements. Guidance on the regulation of exempt disinfectants in Australia provides more information about the requirements for these products.
Disinfectants that make specific claims are regulated as listed disinfectants and are required to be listed in the ARTG prior to their supply.
Examples of the specific claims include, but are not limited to:
Refer to the Disinfectant Claim Guide for further details.
Any claims you make will need to be supported by microbial efficacy studies (refer to TGA instructions for disinfectant testing for details).
The TGA website provides the overview of regulatory pathways and applicable legislations of Disinfectants, sterilants and sanitary products.
Disinfectants which do not make specific claims are exempt and do not need to be listed in the ARTG.
Disinfectants which make specific claims (such as "kills COVID-19") will need to be listed in the ARTG before they can be imported into Australia, supplied within Australia or exported out of Australia.
All disinfectants are exempt from Good Manufacturing Practice (GMP) requirements under Item 13 Schedule 7 of the Therapeutic Goods Regulation 1990.
The person or company importing, supplying or exporting disinfectants is known as the sponsor.
A sponsor must be a resident of Australia or be an incorporated body in Australia and conducting business in Australia where the representative of the company is residing in Australia.
A sponsor has many responsibilities, including:
The listed goods must comply with standards applicable to those goods under part 3 of the Act.
Changes or variations in respect of any information concerning the listed therapeutic goods, being information that would have been relevant* to a decision to list the goods in the Register, including information on the formulation of the listed goods or other aspects of their manufacture, and the labelling of the goods, shall forthwith be notified to the Secretary, or the Secretary's delegate appointed for the purposes of section 28 of the Act, and where necessary*, the change or variation shall not be implemented until approved by the Secretary.
* Refer to guidance on the regulation of disinfectants in Australia.
The sponsor of the listed goods shall keep such records relating to the goods as are necessary:
Where any part of or step in the manufacture in Australia of the listed goods is sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relating to such manufacture shall be kept.
Each sponsor shall retain records of the distribution of all of the sponsor's listed goods for a period of five years and upon the request of the Therapeutic Goods Administration, shall provide the records or copies of the records.
The sponsor of the listed goods shall permit officers who have been authorised under the Regulations to do so to take samples of therapeutic goods and carry out related duties in accordance with the Regulations.
Where the listed goods are distributed regularly overseas as well as in Australia, product recall or any actions other similar regulatory action taken in relation to the goods outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia must be notified to the Therapeutic Goods Administration via Post Market Devices email, postmarketdevices@health.gov.au as soon as the action or information is known to the sponsor.
In relation to listed goods, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to substantiate and support the accuracy of the indications in relation to the listed goods and, upon the request of the Therapeutic Goods Administration, shall produce such evidence.
Sponsors can make an application to include their products in the ARTG using the TGA's Business Services system (TBS).
To create an account, follow the instructions at TGA Business services: getting started with the TGA.
You need to login into your TBS account to access the application forms.
For step-by-step instructions on how to lodge an application, follow the instructions at regulation of listed disinfectants in Australia.
Here are some steps you can take to avoid delays in your application assessment:
It is important that you list the name and quantity of all of the product's ingredients in the application form.
Ingredients included in the formulation of therapeutic goods supplied in Australia must be identified using the relevant Australian Approved Names (AANs). Refer to Regulation of listed disinfectants in Australia for details.
Regulatory decisions and notices about disinfectants are posted on our website.
We have also published a list of frequently asked questions for new disinfectant sponsors.
Advertising for disinfectants (including the label) must comply with all applicable therapeutic goods advertising requirements.
Disinfectants included in the ARTG can only be promoted for those purposes included in the ARTG and (where relevant) the label. The promotion of 'off-label' use to any audience is prohibited (subsections 22(2) to (5) of the Act).
Advertising to the public for disinfectants must comply with the Therapeutic Goods Advertising Code (the Code).
There are particular requirements for 'other therapeutic goods' (which includes disinfectants) in sections 12 and 13 of the Code, which prescribe the mandatory information that must appear in advertising. Disinfectant advertising to the public must comply with all other relevant provisions of the Code.
Before advertising disinfectants to consumers, you should check to see if your advertising material (for example, posters, media and social media advertising) contains restricted and/or prohibited representations, as defined in the Code. If it does, you will need prior approval or permission from the TGA. Refer to the Australian Regulatory Guidelines on Advertising Therapeutic Goods.
Guidance on the regulation of exempt disinfectants in Australia and Guidance on the regulation of listed disinfectants in Australia provide more information about the requirements for advertising these products.
Regulatory affairs consultants offer services, including advice and assistance, in relation to regulatory requirements.
The TGA does not provide a list of consultants. For further information, see Regulatory affairs consultants.
Title changed from 'Disinfectants, sterilants and sanitary products' to 'Understanding regulation of disinfectants, sterilants and sanitary products' as part of migration to new 'Guidance' content type:
Title changed from 'Disinfectants, sterilants and sanitary products' to 'Understanding regulation of disinfectants, sterilants and sanitary products' as part of migration to new 'Guidance' content type:
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